MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRI FUNNEL 20F G-TUBE; GASTROINTESTINAL TUBE AND ACCESSORIES

Catalog Number 000720

Device Problems Burst Container or Vessel (1074); Material Discolored (1170)

Patient Problem No Information (3190)

Event Date 10/25/2016

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a damaged balloon was confirmed and the cause appeared to be use-related.The product returned for evaluation was a 20fr tri-funnel feeding tube.The damage observed in the returned sample was characteristic of over-pressurization (burst) damage.This can occur through over-filling the feeding tube balloon.The appropriate inflation volume is listed on the inflation valve and over-inflation can be avoided by fully draining the balloon prior to inflation.The returned product sample was evaluated and a longitudinally-aligned split in the balloon membrane was observed.This catheter damage was determined to be typical of a burst, and the characteristics observed which supported this type of failure included: tensile weakness in the membrane at the fracture site (due to over-inflation prior to burst).Granular fracture surface texture (typical of tearing failure modes).The split in the balloon was longitudinally aligned which is typical of burst-type failures, and the split traversed the entire length of the balloon.Additionally, residual material and discoloration was seen throughout the sample which established a usage history of the product and suggested the product had worked as intended for a period of time prior to the event.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.These features are characteristically found due to the over-inflation and fracture of the balloon tubing.The product instruction for use (ifu) contains the following information which may be relevant to this type of event, "do not exceed the maximum recommended inflation volume as this may cause excessive pressure on the gastric mucosa and migration of the internal balloon into the peritoneal cavity".A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that the balloon color was observed to be changed when replacing with new one.Saline was not used.The facility experienced the same case before.On 5/31/2017, the returned device has a burst balloon.

• Brand Name: TRI FUNNEL 20F G-TUBE
• Type of Device: GASTROINTESTINAL TUBE AND ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6656786
• MDR Text Key: 78240020
• Report Number: 3006260740-2017-00880
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 00801741037153
• UDI-Public: (01)00801741037153
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K910492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 000720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1